WOBURN, Massachusetts,
October 12, 2010 /PRNewswire/ --
ArQule, Inc. (NASDAQ: ARQL) and Daiichi Sankyo Co., Ltd. (TSE 4568)
today announced the expansion of their research, development and
license agreement for the discovery of novel kinase inhibitors in
the field of oncology. This expanded agreement establishes a third
therapeutic target, with an option for a fourth, in the field of
oncology, and it includes a two-year extension based on the
application of the proprietary ArQule Kinase Inhibitor Platform
(AKIP(TM)) technology.
"This technology has provided us with a unique and innovative
approach for discovery in the treatment of cancer," said Dr.
Hideyuki Haruyama, the Global Head
of Research, Daiichi Sankyo. "We expect that the expansion of this
collaboration will produce other drug candidates and lay the
foundation for future growth in this field."
Consistent with the existing AKIP collaboration, the economic
terms provided for in the expanded agreement include payments for
research support, licensing fees for compounds discovered as a
result of this research, milestone payments related to clinical
development, regulatory review and sales, and tiered royalty
payments on net sales of each product. Daiichi Sankyo will have an
option to license compounds directed to the targets defined under
the agreement following the completion of certain pre-clinical
studies. ArQule retains the option to co-commercialize any
resulting licensed products in the U.S.
"Our initial drug discovery collaboration has identified a
development candidate for one target, and we are optimizing
advanced lead compounds for the other target," said Dr.
Thomas C.K. Chan, chief scientific
officer of ArQule. "The expansion of this collaboration will
continue to deploy AKIP technology to discover inhibitors with
novel modes of action for additional oncology targets over the next
two years."
About the ArQule Kinase Inhibitor Platform (AKIP(TM))
Kinases play pivotal roles in modulating diverse cellular
activities and have been implicated as important mediators of
certain forms of cancer and other diseases. The AKIP(TM) technology
is based on a novel binding mode that leads to inhibition of target
kinases by small molecules that do not compete with adenosine
triphosphate (ATP). ArQule has identified binding sites in more
than 200 kinases involved in multiple therapeutic areas that are
amenable to such non-ATP competitive inhibition.
ArQule's ability to rationally design novel kinase inhibitors
that encompass new chemical spaces allows for an expanding
intellectual property estate. The Company believes that non-ATP
competitive small molecule inhibitors may have fewer off-target
side effects and utility in a broad range of human diseases.
About ArQule
ArQule is a biotechnology company engaged in the research and
development of next-generation, small-molecule cancer therapeutics.
The Company's targeted, broad-spectrum products and research
programs are focused on key biological processes that are central
to human cancers. ArQule's lead product, in Phase 2 and upcoming
Phase 3 clinical development, is ARQ 197, an inhibitor of the c-Met
receptor tyrosine kinase. The Company has also initiated Phase 1
clinical testing with ARQ 621, designed to inhibit the Eg5 kinesin
motor protein. The Company's pre-clinical pipeline includes a
compound designed to inhibit the BRAF kinase. ArQule's current
discovery efforts, which are based on the ArQule Kinase Inhibitor
Platform (AKIP(TM)), are focused on the identification of novel
kinase inhibitors that are potent, selective and do not compete
with ATP (adenosine triphosphate) for binding to the kinase.
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply
of innovative pharmaceutical products to address the diversified,
unmet medical needs of patients in both mature and emerging
markets. While maintaining its portfolio of marketed
pharmaceuticals for hypertension, hyperlipidemia, and bacterial
infections, the Group is engaged in the development of treatments
for thrombotic disorders and focused on the discovery of novel
oncology and cardiovascular-metabolic therapies. Furthermore, the
Daiichi Sankyo Group has created a "Hybrid Business Model," which
will respond to market and customer diversity and optimize growth
opportunities across the value chain. For more information, please
visit http://www.daiichisankyo.com.
Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is a member of the
Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc.,
please visit http://www.dsi.com.
This press release contains forward-looking statements regarding
the Company's ArQule Kinase Inhibitor Platform (AKIP(TM)) and its
related agreement with Daiichi Sankyo. These statements are based
on the Company's current beliefs and expectations, and are subject
to risks and uncertainties that could cause actual results to
differ materially. Positive information about pre-clinical results
does not ensure that later stage pre-clinical or clinical
development will be successful. For example, targets for the kinase
research may not prove to be therapeutically relevant. Compounds
developed through application of the AKIP(TM) platform may not
demonstrate positive activity in pre-clinical in vivo or in vitro
testing or in subsequent clinical trials; in addition, they may not
demonstrate an appropriate safety profile later development as a
result of known or as yet unanticipated side effects. The results
achieved in later stage trials may not be sufficient to meet
applicable regulatory standards. Problems or delays may arise
during clinical trials or in the course of developing, testing or
manufacturing these compounds that could lead the Company or
Daiichi Sankyo to discontinue development. Even if later stage
clinical trials are successful, the risk exists that unexpected
concerns may arise from analysis of data or from additional data or
that obstacles may arise or issues be identified in connection with
review of clinical data with regulatory authorities. Regulatory
authorities may disagree with the Company's or Daiichi Sankyo's
view of the data or require additional data or information or
additional studies. Drug development involves a high degree of
risk. Only a small number of research and development programs
result in the commercialization of a product. Positive pre-clinical
data may not be supported in later stages of development.
Furthermore, ArQule may not have the financial or human resources
to successfully pursue drug discovery in the future. Daiichi Sankyo
may not exercise its option to license compounds even if the
compounds show initial promise. For more detailed information on
the risks and uncertainties associated with the Company's drug
development and other activities, see the Company's periodic
reports filed with the Securities and Exchange Commission. The
Company does not undertake any obligation to publicly update any
forward-looking statements.
Contacts:
William B. Boni Toshiaki Sai
VP, Investor Relations/Corp. Corporate Officer, Corporate
Communications Communications
ArQule, Inc. Daiichi Sankyo, Co., Ltd. (Japan)
+1-781-994-0300 +81-3-6225-1126
